202TiP - A single-arm, open, multicenter and exploratory clinical study of fluzopari combined with apatinib in pts with platinum-sensitive relapsed ovarian cancer first-line treated with a PARP inhibitor

Background

PARP inhibitors (PARPi) have been approved as maintenance therapy for patients with platinum-sensitve recurrent ovarian cancer. Fluzoparib, a novel, potent and orally available PARPi, significantly inhibited PARP1 activity. It had promising antitumor activity in patients with maintenance therapy and platinum-sensitive recurrent ovarian cancer with germline BRCA1/2 mutations who had received previous 2-4 lines of chemotherapy. However, the treatment consensus after PARPi has not been established. Data from the IIIb OReO/ENGOT Ov-38 trial has shown maintenance olaparib rechallenge significantly improved progression-free survival (PFS) vs placebo in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) regardless of their BRCA status. However, it is unclear if a PARPi maintenance monotherapy is sufficient or if the addition of a VEGFR inhibitor is needed. The NIRVANA-R trial investigating niraparib and bevacizumab maintenance therapy in PSROC previously treated with a PARPi is in progress. Therefore, the aim of this trial is to investigate the efficacy and safety of fluzopari combined with apatinib, a VEGFR inhibitor, as a maintenance therapy in PSROC patients who were previously treated with a kind of PARPi.

Trial design

This trial is a multi-center, investigator-initiated, single-arm, exploratory trial of pts with PSROC recruited from eleven Jiangsu sites. This study included patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who received at most 2 previous courses of platinum-containing therapy and had been treated with a PARPi. Patients who had responded to the last platinum regimen (either complete or partial response) were eligible to participate in this study. Thirty patients will be enrolled in phase I and treated with fuzuloparib 100mg and apatinib 250mg for maintenance therapy until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint of the study is PFS, and currently 6 of the planned 30 patients have been recruited.

Clinical trial identification

NCT04734665.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.